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Search / Trial NCT05745896

A Telemedicine Prenatal Care Model on Low Risk Pregnants: The m@Mae-e Study

Launched by TALITA COLOMBO · Feb 23, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Prenatal Care Covid 19 Telemedicine Low Risk Prenatal Line Of Care Health Policy Randomized Clinical Trial

ClinConnect Summary

The m@Mae-e Study is a research trial looking at how telemedicine can help provide prenatal care for low-risk pregnant women. The goal is to see if using telemedicine—where you can have appointments and consultations online—can help reduce anxiety compared to traditional in-person care. The study will follow women from about 6 weeks into their pregnancy until they are 41 weeks pregnant and for 6 weeks after they give birth. Researchers will measure anxiety levels using a simple questionnaire called the General Anxiety Scale 7 (GAD-7).

To participate in this study, women need to be classified as low-risk by their doctor, be between 6 and 13 weeks pregnant at their first appointment, and speak Portuguese. Unfortunately, women with certain conditions such as high blood pressure, diabetes, severe mental health issues, or those who have experienced complications in previous pregnancies cannot take part. If you join, you can expect to receive support and care through telemedicine throughout your pregnancy, while helping researchers understand the value of this approach during a challenging time like the COVID-19 pandemic.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Low-risk pregnant (as classified an attending physician and/or the study's obstetrician);
  • Gestational age less at 13 weeks or more in the moment of the first appointment;
  • Portuguese native speaker.
  • Exclusion Criteria:
  • Pregnant involving: hypertension or diabetes mellitus (any type) previous diagnosis;
  • Obesity (BMI equal or greater than 35 m/kg2;
  • Previous diagnosis of severe Sars-CoV-2 2019-related (COVID-19) infection which needed hospitalization;
  • Previous thromboembolic event;
  • Acute or chronic hematological events/diseases; use of anticoagulants or anti platelet aggregation drugs;
  • Chronic cardiovascular, lung or kidney disease and cancer requiring treatment;
  • Immunosuppression state;
  • Severe mental disorder - major depression, generalized anxiety (and others anxiety-related disorders), bipolar disorder, schizophrenia and personality-related disorders in an uncontrolled manner for at least 1 year;
  • At least more than one abortion;
  • History of premature birth;
  • An enrolled patient living in the same house;
  • Plan to move the city.

About Talita Colombo

Talita Colombo is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on enhancing patient outcomes, the organization specializes in the design, implementation, and management of clinical studies across various therapeutic areas. Talita Colombo prioritizes ethical standards and regulatory compliance, ensuring rigorous methodologies and robust data collection to support the development of safe and effective treatments. Through collaboration with healthcare professionals and research institutions, Talita Colombo strives to contribute meaningfully to the scientific community and improve health care delivery.

Locations

Porto Alegre, Rio Grande Do Sul, Brazil

Patients applied

0 patients applied

Trial Officials

Lucas Helal, MSc, PhD

Study Chair

Federal University of Rio Grande do Sul

Airton T Stein, MD, PhD

Principal Investigator

Federal University of Health Science of Porto Alegre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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